Is a Pre-IND Meeting Necessary for Your Program?

Abstract

Sponsors often ask this question in one form or another: “is a pre-IND meeting really necessary for my program?” This is just one of the many important questions for the sponsor as the early development project moves forward to the next vital stage. For a majority of the IND preparation and submission projects which Aleon Pharma International, Inc. (“Aleon”) has managed, the sponsor ultimately decided that having a pre-IND meeting is necessary. These pre-IND meetings added significant value. We understand that every program is different and faces its own unique challenges. The decision on whether or not to have a pre-IND meeting is very important to the sponsor and it should not be taken lightly...